Venous Stenosis, Venous Occlusion
Conditions
Keywords
Arteriovenous Fistula (AVF), Arteriovenous Graft (AVG), AV fistula, AV graft
Brief summary
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
Detailed description
Prospective, multicenter, observational study to evaluate the Merit WRAPSODY™ Endoprosthesis for treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft (The WRAP Registry)
Interventions
Target Lesion Primary Patency (TLPP)
Sponsors
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject provides written informed consent for study participation. 2. Subject is male or female, with an age ≥ 18 years at date of enrollment. 3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 24 months. 4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon 5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session. 6. Subject has stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft and is treated with WRAPSODY Endoprosthesis System in accordance with device instructions for use.
Exclusion criteria
1. Subject has a planned surgical revision of access site. 2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. 3. Subject has an uncorrectable coagulation disorder. 4. Known hypersensitivity to nickel titanium alloy. 5. Subject's hemodialysis access is anticipated to be abandoned within 6 months. 6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure. 7. Full expansion of a Percutaneous Transluminal Angioplasty (PTA) balloon cannot be achieved during predilatation. 8. Device would be placed in the Superior Vena Cava 9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint) | 6 months | Proportion of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion. |
| Proportion of subjects without any localized or systemic safety events (Primary Safety Endpoint) | 30 days | Proportion of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with Target Lesion Primary Patency | 12 and 24 months | Proportion of subjects with Target Lesion Primary Patency |
| Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) | 6, 12 and 24 months | Proportion of subjects with Assisted Target Lesion Primary Patency (aTLPP) |
| Proportion of subjects with Access Circuit Primary Patency (ACPP) | 6, 12 and 24 months | Proportion of subjects with Access Circuit Primary Patency (ACPP) |
| Rates of procedure- and device-related adverse events | Index procedure, 30 days, and months 6 | Rates of procedure- and device-related adverse events |
Countries
Australia, Brazil, Germany, Greece, Israel, Netherlands, New Zealand, Portugal, United Kingdom
Outcome results
None listed